ABIONYX Pharma has granted a named patient Temporary Authorization for Use (ATU nominative) for CER-001 in an untreated, ultra-rare renal disease. As part of its strategy to focus on existing assets and given the current availability of CER-001 vials, ABIONYX Pharma has committed to supply the product free of charge over a period of three months.
In France, the use of proprietary drugs that do not yet benefit from a market authorization (AMM) and that are not the subject of a clinical trial, are subject to obtainment of a named patient Temporary Authorization for Use from the ANSM. The current data do not allow presumption of a favourable benefit-risk ratio for the use of CER-001 in the context of this named patient Temporary Authorization for Use.
In particular, a named patient Temporary Authorization for Use is granted by the ANSM under the following conditions:
- The product is meant to treat, prevent or diagnose a severe or rare disease,
- There is no appropriate treatment available on the market, with no possibility to...